June 22, 2011

June 21, 2011, 8:14 p.m. EDT

CDC Joins National Association of People With AIDS in Promoting Life Saving HIV Testing Initiatives

SILVER SPRING, MD, Jun 21, 2011 (MARKETWIRE via COMTEX) -- Tens of thousands of Americans are expected to be tested for HIV at events from coast to coast organized as part of the National Association of People with AIDS' (NAPWA) National HIV Testing Day (NHTD) on June 27th, 2011. A list of testing events nationwide is available at the Centers for Disease Control and Prevention website created to promote the events. Awareness is spreading online of events nationwide on Twitter, using #NHTD.

National HIV Testing Day is conducted by NAPWA in partnership with ACT Against AIDS, The Black AIDS Institute, Gilead, GetYourselfTested.org, GreaterThan.org, Health HIV, OraSure Technologies, Inc., and The Mayors Campaign Against HIV. The CDC provides a comprehensive list of testing locations open nationwide on National HIV Testing Day.

"This year, more than ever before, we know that HIV testing saves lives," said Frank Oldham, Jr., President and CEO of NAPWA. "Knowing your HIV status and seeking medical treatment in the event of a positive test not only extends survival for the person diagnosed, but it also helps stop the spread of the disease by empowering people living with HIV/AIDS to reduce transmission. This is why NAPWA founded National HIV Testing Day in 1995."

Mayors Campaign Against HIV Brings the Testing Message Home This year, NAPWA is also hosting the seventh annual Mayors Campaign Against HIV, in partnership with OraSure Technologies. Last year, more than 100 Mayors across the country supported National HIV Testing Day (NHTD) by hosting HIV testing campaigns in their cities, conducting news conferences to discuss local HIV testing resources, issuing proclamations in support of NHTD and even stepping forward and getting tested themselves.

NAPWA and OraSure partner with mayors and testing organizations throughout the United States to highlight the importance of routine HIV testing. NAPWA also collaborates with Congressional lawmakers to bring a renewed focus to testing and prevention initiatives.

"We are very pleased to be joining forces with NAPWA and participating mayors again this year as we publicly unite in the fight against HIV/AIDS through our Mayors Campaign Against HIV," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are extremely proud that our technology is a driving force in getting more people tested and enabling HIV-positive individuals to learn their status earlier so they can access care sooner."

National NHTD Media Events For the fifth year in a row, NAPWA and U.S. Representative Barbara Lee (D-CA) will host a news conference (held June 24th -- call contact for details) on U.S. Capitol grounds to focus attention on the HIV epidemic and the need for those at risk for HIV to get tested. Other expected and invited speakers include Jeffrey Crowley, Director, White House Office of HIV/AIDS Policy and Mayor Vincent Gray, Washington, D.C.

"Up to 70 percent of new infections come from people who are unaware of their HIV status," said Representative Lee. "We must do everything we can to raise awareness in our communities about the benefits of testing whether on NAPWA's National HIV Testing Day, or any other day. Testing is a very important tool in the global response to this epidemic."

NAPWA will also join OraSure for a community observance of NHTD in New York City at the opening of the NASDAQ Stock Market on Monday, June 27, 2011.

A Shifting Legal Landscape: HIV Testing, Prevention, and Criminalization NAPWA recognizes early diagnosis and treatment of HIV infections as an important step towards reducing the number of new infections and controlling future public healthcare costs. The public interest in early detection and treatment is so compelling that legal and behavioral barriers to testing should be removed wherever they exist.

NAPWA therefore calls on states that do not offer anonymous HIV testing to do so, and for those that actually forbid it to change their laws. NAPWA also calls on states to repeal laws making certain behaviors illegal for people who know they have HIV but not for others. The laws do nothing to reduce the number of new infections. They do, however, give people who think they may be living with HIV but don't know for sure a powerful practical incentive not to get tested. By reducing the number of tests, the laws may actually increase the number of new infections.

HIV Testing Facts and Who Needs to Get Tested? Today, CDC estimates approximately 21 percent of the 1.1 million Americans living with HIV are unaware of their HIV status. These individuals unintentionally cause 54 to 70 percent of America's nearly 60,000 new infections annually. Seventy-five percent of HIV+ people will change risky behaviors when they learn their status. Risk-based testing is NOT reaching the goal of identifying all HIV+ people.

The CDC recommends testing for everyone ages 13 to 64. Everyone should be tested once and then decide how regularly to be tested. It's especially important for people in high-risk groups to get tested regularly. These include:

-- Sexually active younger teenagers;

-- Poor women of color;

-- Men who have sex with men (MSM);

-- People who inject or snort drugs with others;

-- Sex workers, including anyone who has to exchange sexual favors for necessities of life; and

-- People who live in HIV "hot spots," sometimes only a few blocks in area, where the HIV infection rate is so high that anyone who is sexually active is at risk.

About NAPWA's NHTD Take the Test, Take Control Campaign and Media Materials NAPWA believes voluntary HIV counseling and testing is a critical first step in taking control and responsibility over one's health, hence our message: "Take the Test, Take Control."

In partnership with the Greater Than AIDS Campaign and OraSure Technologies, NAPWA has distributed 70,000 NHTD posters to local health departments, community clinics and other community-based organizations that engage in HIV testing initiatives, to ensure that communities have the resources they need to mount an effective HIV testing campaign.

Electronic versions of the joint Greater Than AIDS Campaign (Get Yourself Tested) and the NAPWA's NHTD campaign (Take the Test, Take Control) can be found at www.greaterthan.org and NAPWA . Click here to read NAPWA's guidelines for routine testing and counseling.

The National Association of People with HIV/AIDS (NAPWA) is the largest and oldest advocacy group of and for people living with HIV/AIDS. The organization created AIDSWatch, the largest annual legislative briefing day by people living with HIV/AIDS, as well as National HIV Testing Day, June 27th, 2011. NAPWA's Healthy Living Summit in Dallas, August 7 to 10, 2011 is the preeminent educational forum for the daily health needs of people living with HIV/AIDS. More information is available at www.napwa.org . Follow us on Twitter @NAPWAUS.

CONTACT:
Peter Kronenberg
240 247-1025
Email Contact

SOURCE: National Association of People with AIDS

Source

Popular Nonprofit Organization Falls Victim to Economic Downturn

North Miami, FL, June 22, 2011 --(PR.com)-- ALERT Health, a nonprofit organization providing preventive health counseling, testing, and referral will close its office on June 30th due to funding constraints.

Founded in 1997 as “Hep-C ALERT” by Andi Thomas, a patient affected by chronic Hepatitis C, its original mission was to raise awareness and assist people affected by this insidious disease. Upon moving the organization to downtown North Miami in 2001, Thomas began offering screenings for other diseases, including HIV, sexually transmitted infection, Hepatitis B, blood pressure, and cholesterol. Her vision of providing several clinical screenings in a single visit, in a welcoming setting, and at no cost removed major barriers to preventive care and led the agency to a new name and updated mission in 2007.

Thomas’ approach proved popular with local residents, particularly uninsured young adults. Jess Bardisa, Development Director, said, “We experienced a 900% increase in client visits between 2004 and 2008 – from seeing 60 people per month to more than 600.” Bardisa explained that more than half of clients seen each month were new to the organization and nearly all were referred by other clients. “Our service philosophy created this great word-of-mouth referral network. We didn’t even advertise.” The organization has served over 33,000 people since 1997.

Thomas said, "The economic downturn and shifting public health priorities has taken its toll on our funding. I’ve done everything in my power to keep the agency running after several critical grants failed to come through in early 2009.” As one of a handful of expert Hepatitis C organizations in the country, and the only full-time HIV testing site serving the northeast sector of Miami-Dade, thousands of people will be left without a place to go. She continued, “I am deeply concerned about the void that will be left once ALERT Health closes its doors.”

“There are no other organizations in North Miami that can step in and handle the 300 plus clients we see each month, and none locally that offer support for people with Hepatitis C,” said Jon Kelly, the organization’s Project Coordinator. Thomas emphasized that “ALERT Health’s exit couldn’t come at a worse time. We just celebrated the approval of a new class of Hepatitis C drugs last month; the first major treatment breakthrough in a decade.” ALERT Health is working with local health departments to identify other organizations to refer clients to.

ALERT Health, Inc. mission is to improve health and quality of life for people affected by chronic disease, by providing accessible, integrated, preventive care. For more information, please visit http://www.alerthealth.org/.

###

Contact Information

ALERT Health, Inc.
Andi Thomas or Jess Bardisa
305-893-7992 x101 or x103
info@alerthealth.org
http://www.alerthealth.org/

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Pharmasset Announces Issuance of U.S. Patent for PSI-7977

-- USPTO grants patent covering the anti-HCV drug PSI-7977

PRINCETON, N.J., June 22, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that the United States Patent and Trademark Office has issued U.S. patent 7,964,580 ("the '580 patent") titled "Nucleoside Phosphoramidate Prodrugs". This patent generally relates to the composition of matter of PSI-7977 and its diastereomeric mixture for the treatment of hepatitis C virus (HCV). PSI-7977, a uracil nucleotide analogue polymerase inhibitor of HCV, is being studied in multiple phase 2 trials.

"Today's announcement is a credit to our in-house research team in discovering new HCV product candidates," stated Schaefer Price, Pharmasset's President and Chief Executive Officer. "As the '580 patent is not due to expire until 2029, not including any patent term extension, it should become an important part of a growing portfolio of issued patents covering PSI-7977."

About PSI-7977

PSI-7977, one of two diastereomers comprising PSI-7851, is a prodrug of a uracil nucleotide analog polymerase inhibitor we are developing for the treatment of chronic HCV infection. PSI-7977 has completed a 28 day phase 2a trial in combination with peg-interferon and ribavirin (Peg-IFN/RBV) and is currently being tested in four phase 2b studies: the PROTON trial in combination with peg-IFN/RBV in HCV genotype 1, 2 or 3 patients; the ATOMIC trial with peg-IFN/RBV in HCV genotypes 1,4,5,6; the ELECTRON trial, an interferon sparing /interferon free study in HCV genotypes 1,2 and 3 and a study with Bristol-Myers Squibb's NS5a inhibitor, BMS-790052, as part of an interferon free regimen. Pharmasset also anticipates initiating its own interferon free trial with PSI-7977 and PSI-938, a guanine nucleotide polymerase inhibitor in the third calendar quarter 2011.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is the development of oral therapeutics for the treatment of hepatitis C virus (HCV) infection. Our research and development efforts are focused on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates advancing in trials in various populations. Our pyrimidine, PSI-7977, an unpartnered uracil nucleotide analog, is currently under study in four Phase 2b trials in patients with HCV genotypes 1 through 6, including abbreviated duration interferon and interferon-free regimens. Our purine, PSI-938, an unpartnered guanosine nucleotide analog, recently reported safety and efficacy data from 14 days of monotherapy as well as 14 days in combination with the pyrimidine, PSI-7977. An SVR-endpoint study of the purine-pyrimidine combination is anticipated to begin in the third quarter of 2011. Mericitabine (RG7128) continues in two Phase 2b trials and one interferon-free trial being conducted through a strategic collaboration with Roche.

Pharmasset Forward-Looking Statements

Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release that are not historical facts are "forward-looking statements," that involve risks, uncertainties, and other important factors, including, without limitation, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of risks, uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2010 and our Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission and discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission.

CONTACT: Richard Smith, +1-609-865-0693, rsmith@pharmasset.com

SOURCE Pharmasset, Inc.

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Posted June 22, 2011

Ouwe-Missi-Oukem-Boyer O. PLoS ONE. 2011;doi:10.1371/journal.pone.0016034.

New findings suggest a possible epidemiological interaction between hepatitis C, hepatitis B and Plasmodium falciparum infections. Age was a key factor in this association and hepatitis C virus led to slower emergence of P. falciparum in the blood, according to Odile Ouwe-Missi-Oukem-Boyer, PhD, and colleagues.

In the pilot study, researchers assigned 319 participants, aged between 13 and 85 residing in Dienga, Africa, to a curative antimalarial treatment. Microscopy and polymerase chain reaction (PCR) were used to monitor the emergence of P. falciparum in participant’s blood every 2 weeks for 1 year duration.

Sixty-five participants tested positive for malaria parasites; 61 were HCV carriers; 36 were HBV carriers; and P. falciparum was detected in 203 patients at 1 year follow-up. Of those with P. falciparum, 25 were HBV carriers and 28 were HCV carriers. Most HBV carriers were younger than 30 years; the likelihood of HCV infection increased significantly with age.

Median time to P. falciparum emergence in blood was 140 days and 120 days in HBV-negative and positive participants, and 135 days and 224 days in HCV-negative and positive participants, respectively. Compared with those without HCV infection, HCV carriage was associated with a slower emergence of P. falciparum infection in the blood.

“HCV carrier status but not HBV carrier status was significantly associated with slower emergence of malaria parasites in univariate analysis, along with older age and self-medication,” the researchers wrote. “The relation with HCV carrier status was confirmed in multivariate analysis, although the P value was just above the threshold of significance. As age is a confounding factor, the influence of HCV infection on the natural course of P. falciparummalaria would be best examined in a case-control study.”

Disclosure: The researchers report no relevant financial disclosures.

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Gold nanoparticles help earlier diagnosis of liver cancer

Public release date: 22-Jun-2011

Contact: Richard Lewis
Richard_Lewis@brown.edu
401-863-3766
Brown University

PROVIDENCE, R.I. [Brown University] — Hepatocellular carcinoma is the most common cancer to strike the liver. More than 500,000 people worldwide, concentrated in sub-Saharan Africa and Southeast Asia, are diagnosed with it yearly. Most of those afflicted die within six months.

A big obstacle to treatment of liver cancer is the lack of early diagnosis. Current techniques, including ultrasound, CT and MRI scans, spot tumors only when they have grown to about 5 centimeters in diameter. By that time, the cancer is especially aggressive, resisting chemotherapy and difficult to remove surgically.

Now a research team led by Brown University reports some promising results for earlier diagnosis. In lab tests, the team used gold nanoparticles ringed by a charged polymer coating and an X-ray scatter imaging technique to spot tumor-like masses as small as 5 millimeters. The approach, detailed in the American Chemical Society journal Nano Letters, marks the first time that metal nanoparticles have been used as agents to enhance X-ray scattering signals to image tumor-like masses.

"What we're doing is not a screening method," said Christoph Rose-Petruck, professor of chemistry at Brown University and corresponding author on the paper. "But in a routine exam, with people who have risk factors, such as certain types of hepatitis, we can use this technique to see a tumor that is just a few millimeters in diameter, which, in terms of size, is a factor of 10 smaller."

The team took gold nanoparticles of 10 and 50 nanometers in diameter and ringed them with a pair of 1-nanometer polyelectrolyte coatings. The coating gave the nanoparticles a charge, which increased the chances that they would be engulfed by the cancerous cells. Once engulfed, the team used X-ray scatter imaging to detect the gold nanoparticles within the malignant cells. In lab tests, the nontoxic gold nanoparticles made up just 0.0006 percent of the cell's volume, yet the nanoparticles had enough critical mass to be detected by the X-ray scatter imaging device.

"We have shown that even with these small numbers, we can distinguish these [tumor] cells," Rose-Petruck said.

The next step for the researchers is on the clinical side. Beginning this summer, the group will attach a cancer-targeting antibody to the nanoparticle vehicle to search for liver tumors in mice. The antibody that will be used was developed by Jack Wands, director of the Liver Research Center at Rhode Island Hospital and professor of medical science at the Warren Alpert Medical School of Brown University.

"We have developed a monoclonal antibody that targets a cell surface protein highly expressed on liver cancer cells," Wands said. "We plan to couple the antibody to the gold nanoparticles in an attempt to detect the growth of early tumors in the liver by X-ray imaging."

The researchers say the X-ray scatter imaging method could be used to detect nanoparticle assemblies in other organs. "The idea should be that if you can figure out to get that [nanoparticle] to specific sites in the body, you can figure out how to image it," said Danielle Rand, a second-year graduate student in chemistry and the first author on the paper.

###

Contributing authors include Yanan Liu from Brown, Wands, Zoltan Derdak and Vivian Ortiz from the Liver Research Center, and Milan Taticek at the Czech Technical University in Prague.

The National Institutes of Health and the U.S. Department of Energy funded the research. Rand's work was supported by the U.S. Department of Education through the Graduate Assistance in Areas of National Need (GAANN) fellowship, administered by the Institute for Molecular and Nanoscale Innovation at Brown.

Source
June 22, 2011

-INCIVEK was recently approved by the FDA and is now available for people with the most common form of chronic hepatitis C who are new to treatment and those who were treated before but not cured-

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from two Phase 3 studies of INCIVEK™ (telaprevir) tablets, which showed that INCIVEK (in-SEE-veck) combination therapy significantly improved rates of sustained viral response (SVR, or viral cure) in a broad group of people with genotype 1 chronic hepatitis C who were new to treatment and those who were treated previously but not cured (relapsers, partial responders and null responders). Data from these studies, which included nearly 2,000 people, are published in the June 23, 2011 issue of NEJM.

In the ADVANCE study, INCIVEK combination therapy significantly improved viral cure rates in people who were new to treatment compared to those who received pegylated-interferon and ribavirin alone, two other medicines approved for hepatitis C. The majority of people who received INCIVEK combination therapy in this study were able to complete treatment in 24 weeks — half the time needed if they were to have taken pegylated-interferon and ribavirin alone. In the REALIZE study, which included people who were treated previously but not cured, viral cure rates were three-to-six-times higher with INCIVEK combination therapy compared to treatment with pegylated-interferon and ribavirin alone. Rash and anemia were the most common side effects reported with INCIVEK, which led to treatment discontinuation in about 1 percent of people in clinical studies.

"In the ADVANCE study, 79 percent of people with hepatitis C who had not been treated previously achieved a viral cure with INCIVEK combination therapy and the majority were able to cut treatment time in half," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College, lead author and principal investigator for the ADVANCE study. "The results from this landmark study represent a paradigm shift in the treatment of hepatitis C and give us a new reason to encourage people to get tested and treated to potentially avoid the life-threatening consequences that can be associated with the disease."

"Many people with chronic hepatitis C who were treated previously but not cured have been waiting for new medicines, like INCIVEK, that offer a better chance to clear the virus," said Stefan Zeuzem, M.D., Professor of Medicine and Chief of the Department of Medicine at the JW Goethe University Hospital, Frankfurt, Germany, lead author and principal investigator for the REALIZE study. "In the REALIZE study, 86 percent of people who relapsed after being treated previously achieved a viral cure with INCIVEK combination therapy."

"The publication of these groundbreaking data follows the recent approval of INCIVEK, and it's exciting to know that some people are now completing their first month of INCIVEK combination treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex.

On May 23, 2011, the U.S. Food and Drug Administration (FDA) approved INCIVEK for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). The approval was based on data from three Phase 3 studies, including ADVANCE and REALIZE. The SVR (viral cure) rates included below are based on the approved analysis conducted by the FDA and Vertex and can be found in the Prescribing Information for INCIVEK.

People who received INCIVEK combination treatment achieved significantly higher rates of SVR, or viral cure, compared to those who received pegylated-interferon and ribavirin alone, regardless of prior treatment experience:

ADVANCE:
-- People new to treatment: 79 percent vs. 46 percent

REALIZE:
-- Relapsers: 86 percent vs. 22 percent
-- Partial responders: 59 percent vs. 15 percent
-- Null responders: 32 percent vs. 5 percent

INCIVEK was studied in all three groups of people who were treated previously but not cured. These groups included:

• Relapsers: defined as people whose hepatitis C virus was undetectable after a full course of previous treatment, but whose virus became detectable during the follow-up period;

• Partial responders: defined as people who achieved at least a 2 log10 reduction in hepatitis C virus at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy; and

• Null responders: defined as people who achieved a less than 2 log10 reduction in hepatitis C virus at week 12 of a prior course of therapy. INCIVEK is the only newly approved medicine that has been studied in null responders.

Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems and taste changes.

For more information on INCIVEK, including full Prescribing Information, please visit http://www.incivek.com/.

About the ADVANCE and REALIZE Studies

ADVANCE and REALIZE were pivotal, Phase 3 randomized, double-blind, placebo-controlled, global studies, which evaluated INCIVEK in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin). Both of these studies were part of a nearly 4,000-person clinical development program for INCIVEK. ADVANCE included 1,088 people who were new to treatment. REALIZE included 662 people who were treated previously but not cured, including relapsers, partial responders and null responders. The primary endpoint of these studies was SVR, or viral cure, in people who received INCIVEK combination therapy compared to those who received treatment with pegylated-interferon and ribavirin alone.

About INCIVEK

INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication. INCIVEK (750 mg) is given as two 375-mg tablets three-times daily for 12 weeks in combination with pegylated-interferon and ribavirin. Each monthly package of INCIVEK contains four weekly boxes that include daily blister strips to help patients keep track of their doses. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination therapy, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks. All other patients receive a total of 48 weeks of treatment.

Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Telaprevir was approved by the FDA in May 2011 and will be marketed in the United States under the brand name INCIVEK (in-SEE-veck). In Canada, telaprevir is under Priority Review by the Therapeutic Product Directorate (TPD) of Health Canada. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. In December 2010, Janssen announced that the European Medicines Agency (EMA) accepted telaprevir for Accelerated Assessment in Europe. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.

Indication

INCIVEK™ (telaprevir) tablets is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.

It is not known if INCIVEK is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. Ribavirin may cause birth defects or death of an unborn baby. Therefore, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.

INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life threatening. There are certain medicines you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

INCIVEK can cause serious side effects including rash and anemia. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Tell your healthcare provider about any side effect that bothers you or doesn't go away.

Please see full Prescribing Information for INCIVEK, including the Medication Guide, available at http://www.incivek.com/.

You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 OR 1-800-332-1088 or www.fda.gov/medwatch. You may also report side effects to Vertex at 1-877-824-4281 .

INCIVEK™ is a trademark of Vertex Pharmaceuticals Incorporated.

PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.

About Hepatitis C

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver.1 Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer.1 Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain.1

Unlike HIV and hepatitis B virus, chronic hepatitis C is curable.2 However, approximately 60 percent of people do not achieve SVR,3,4,5 or viral cure,6 after treatment with 48 weeks of pegylated-interferon and ribavirin alone. If treatment is not successful and a person does not achieve a viral cure, they remain at an increased risk for progressive liver disease.7,8

More than 170 million people worldwide are chronically infected with hepatitis C.6 In the United States, nearly 4 million people have chronic hepatitis C and 75 percent of them are unaware of their infection.9 Hepatitis C is four times more prevalent in the United States compared to HIV.9 The majority of people with hepatitis C in the United States were born between 1946 and 1964, accounting for two of every three people with chronic hepatitis C.10 Hepatitis C is the leading cause of liver transplantations in the United States and is reported to contribute to 4,600 to 12,000 deaths annually.11,12 By 2029, total annual medical costs in the United States for people with hepatitis C are expected to more than double, from $30 billion in 2009 to approximately $85 billion.9

About Vertex

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases.

Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

(VRTX - GEN)

1 Centers for Disease Control and Prevention. Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at: http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf. Accessed March 21, 2011.

2 Pearlman BL and Traub N. Sustained Virologic Response to Antiviral Therapy for Chronic Hepatitis C Virus Infection: A Cure and So Much More. Clin Infect Dis. 2011 Apr;52(7):889-900.

3 Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001;358:958-965.

4 Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002;347:975-982.

5 McHutchison JG, Lawitz EJ, Shiffman ML, et al; IDEAL Study Team. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med. 2009;361:580-593.

6 Ghany MG, Strader DB, Thomas DL, Seeff, LB. Diagnosis, management and treatment of hepatitis C; An update. Hepatology. 2009;49 (4):1-40.

7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K, Lok AS. Outcome of sustained virological responders and non-responders in the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl 4):357A (Abstract 115).

8 Veldt BJ, Heathcote J, Wedmeyer H. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Annals of Internal Medicine. 2007; 147: 677-684.

9 Institute of Medicine of the National Academies. Hepatitis and liver cancer: a national strategy for prevention and control of hepatitis B and C. Colvin HM and Mitchell AE, ed. Available at: http://www.iom.edu/Reports/2010/Hepatitis-and-Liver-Cancer-A-National-Strategy-for-Prevention-and-Control-of-Hepatitis-B-and-C.aspx. Updated January 11, 2010. Accessed March 21, 2011.

10 Pyenson B, Fitch K, Iwasaki K. Consequences of hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver disease. Available at: http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009. Accessed March 21, 2011. This report was commissioned by Vertex Pharmaceuticals, Inc.

11 Volk MI, Tocco R, Saini S, Lok, ASF. Public health impact of antiviral therapy for hepatitis C in the United States. Hepatology. 2009;50(6):1750-1755.

12 Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: A multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010;138:513-521.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6770407&lang=en

Vertex Contacts:

Media:
Dawn Kalmar, 617-444-6992
Amy Pasqua, 617-444-6992
Zachry Barber, 617-444-6992
mediainfo@vrtx.com
or
Patient Inquiries: 1-855- 837-3894
or
Investors:
Michael Partridge, 617-444-6108
Lora Pike, 617-444-6755
Matthew Osborne, 617-444-6057

Source: Vertex Pharmaceuticals Incorporated

Source
Public release date: 22-Jun-2011

Contact: Andrew Klein
ank2017@med.cornell.edu
212-821-0560\
New York- Presbyterian Hospital/Weill Cornell Medical Center/Weill Cornell Medical College

NewYork-Presbyterian/Weill Cornell physician-scientist leads study reporting that FDA-approved telaprevir-based regimen acts faster and offers a stronger viral cure than standard treatment

NEW YORK (June 23, 2011) -- The drug telaprevir (Incivek) provides a dramatic improvement in the treatment of the most common form of hepatitis C infection, says an international team of investigators led by Dr. Ira M. Jacobson of NewYork-Presbyterian Hospital/Weill Cornell Medical Center.

Their study, published in today's edition of the New England Journal of Medicine, led to approval of the agent for patient use by the U.S. Food and Drug Administration on May 23.

Results of the ADVANCE trial showed that telaprevir combined with standard therapy (pegylated-interferon and ribavirin) cured the virus in 75 percent of patients treated compared with 44 percent of patients who received standard therapy alone.

Furthermore, of the nearly 60 percent of telaprevir-treated patients who had undetectable viral levels at weeks 4 and 12 of treatment, and who were eligible by the terms of the study to receive 24 weeks of total treatment -- half the time required for standard treatment -- approximately 90 percent were cured.

Telaprevir represents a "quantum leap forward into a new era of hepatitis C therapy," says Dr. Jacobson, chief of the Division of Gastroenterology and Hepatology and the Vincent Astor Distinguished Professor of Medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. "This agent directly targets the virus and, together with the also recently introduced protease inhibitor boceprevir, is the first of a coming wave of new treatments that will help the medical community eradicate hepatitis C infection in a majority of patients."

More than 3 million people in the United States have chronic hepatitis C virus (HCV) infection. The infection, which is usually transmitted by blood, settles in the liver, which mounts a chronic immune response in an attempt to clear it. This persistent inflammation can lead to liver damage, cirrhosis or failure of the organ. Treatment to eradicate the virus often fails, leaving patients with few options other than a liver transplant.

Dr. Jacobson considers the approval of telaprevir to be a major breakthrough in the more than two-decade search for more effective HCV treatment. He was part of the first multicenter study of interferon therapy that stimulates the body's defenses against HCV, and he was also involved in studies that established that the addition of ribavirin to pegylated-interferon was beneficial as well as the initial studies demonstrating the effectiveness of interferon itself. In 1999, he helped create the Center for the Study of Hepatitis C and serves as the Center's medical director. A joint program of The Rockefeller University and NewYork-Presbyterian/Weill Cornell, the Center is a comprehensive, multidisciplinary center dedicated to the study of HCV and liver disease.

Telaprevir is similar in concept to drugs used to treat HIV. It is a protease inhibitor that shuts down the enzyme that processes the protein product of the viral genome after HCV infects human cells. The drug is effective against HCV genotype 1, which is responsible for nearly three-fourths of all hepatitis C infections in the United States and is also the predominant genotype in Europe, Japan and elsewhere.

In the ADVANCE clinical trial of which Dr. Jacobson served as principal investigator, 1,088 untreated patients diagnosed with HCV genotype 1 were assigned to one of three treatment arms: standard therapy for 48 weeks, or telaprevir combined with standard therapy for 8 or for 12 weeks, followed by standard therapy alone for a total treatment duration of either 24 or 48 weeks. The researchers found that sustained virologic response occurred in significantly more patients receiving 12 weeks (75 percent) or 8 weeks (69 percent) of telaprevir than with standard therapy alone (44 percent). (Note: The drug's package insert reflects higher SVR rates of 79 percent, 72 percent, and 46 percent, respectively, arising from revised analyses). In all, 58 percent of telaprevir-treated patients received 24 weeks of total treatment.

There were substantial benefits of telaprevir in subgroups of patients who do not generally respond well to standard therapy, Dr. Jacobson says. For example, 62 percent of participating African-American patients achieved a viral cure with the telaprevir-based regimen, compared with 25 percent of African-Americans treated with standard therapy. In addition, 62 percent of patients with advanced liver cirrhosis achieved a viral cure with telaprevir compared with 33 percent of similar patients on standard therapy. "We have closed the gap in cure in these populations," he says.

The results confirm the findings of the U.S. Phase 2 PROVE1 study, which was co-authored by Dr. Jacobson, and the European PROVE2 study; both studies were published April 30, 2009, in the New England Journal of Medicine.

Dr. Jacobson notes that telaprevir use does add to the side effects of standard therapy, but the marked increment of efficacy outweighs these side effects, adding that the risk-benefit ratio is very favorable for telaprevir.

"Telaprevir is not the end of the story. There are many exciting drugs being evaluated," he says. "Our most cherished goal is to cure HCV in all patients with a cocktail of fast-acting and well-tolerated drugs that have direct action against the virus or, in some cases, may target factors in the host that contribute to HCV replication or its consequent liver disease. Many lives will be saved."

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Telaprevir was developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex provided funding for the study. Dr. Jacobson has received consulting fees and/or grant support from Vertex, Roche (maker of peginterferon and ribavirin) and Schering-Plough (maker of peginterferon and ribavirin).

Co-authors include Dr. John G. McHutchison and Dr. Andrew J. Muir from Duke Clinical Research Institute and Division of Gastroenterology, Duke University Medical Center, Durham, N.C.; Dr. Geoffrey Dusheiko, from Royal Free Hospital, Centre for Hepatology, London, United Kingdom; Dr. Adrian M. Di Bisceglie from Saint Louis University School of Medicine, Saint Louis, Mo.; Dr. K. Rajender Reddy from the University of Pennsylvania, Division of Gastroenterology, Philadelphia, Pa.; Dr. Natalie H. Bzowej from the California Pacific Medical Center, San Francisco, Calif.; Dr. Patrick Marcellin from Hôpital Beaujon, Service d'Hépatologie and INSERM CRB3, Clichy, France; Dr. Peter Ferenci from the University of Vienna, Vienna, Austria; Dr. Robert Flisiak from Medical University of Bialystok, Department of Infectious Diseases and Hepatology, Bialystok, Poland; Dr. Jacob George from Storr Liver Unit, Westmead Millennium Institute for Medical Research and Westmead Hospital, University of Sydney, Westmead, Australia; Dr. Mario Rizzetto from the University of Turin, Department of Gastroenterology, Turin, Italy; Dr. Daniel Shouval from Hadassah-Hebrew University Hospital, Liver Unit, Jerusalem, Israel; Dr. Ricard Sola from Hospital del Mar, IMIM, Universitat Autónoma de Barcelona, Barcelona, Spain; Dr. Ruben A. Terg from Hospital de Gastroenterología Dr Bonorino Udaondo, Buenos Aires, Argentina; Dr. Eric M. Yoshida from the University of British Columbia and Vancouver General Hospital, Vancouver, B.C., Canada; Dr. Nathalie Adda, Leif Bengtsson, Dr. Abdul J. Sankoh, Dr. Tara L. Kieffer, Dr. Shelley George and Dr. Robert S. Kauffman from Vertex Pharmaceuticals Incorporated, Cambridge, Mass.; and Dr. Stefan Zeuzem from Johann Wolfgang Goethe University Medical Center, Department of Internal Medicine, Frankfurt am Main, Germany, for the ADVANCE Study Team.

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NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit http://www.nyp.org/ and weill.cornell.edu.

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Drug Ups Response Rate in Refractory Hepatitis C

By Michael Smith, North American Correspondent, MedPage Today
Published: June 22, 2011
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston.

The protease inhibitor, telaprevir (Incivek), markedly improved response rates in patients with difficult-to-treat hepatitis C virus (HCV) infection, compared with standard therapy, according to two studies reported in the June 23 issue of the New England Journal of Medicine.

The improvement was particularly dramatic among patients who had previously failed standard therapy, according to Stefan Zeuzem, MD, of Johann Wolfgang Goethe University Hospital in Frankfurt, Germany, and colleagues.

In one arm of their REALIZE study, 88% of patients getting telaprevir, in combination with standard therapy, had a sustained virological response (SVR), defined as no detectable virus 24 weeks after the final treatment dose.

In contrast, just 24% of patients attempting standard therapy for a second time had a sustained response, Zeuzem and colleagues reported.

Only about 40% of patients with the most difficult-to-treat variety of HCV, the so-called genotype 1, respond to standard treatment with pegylated interferon alfa-2a and ribavirin.

But in the ADVANCE study, the second one in this issue of the journal, the rate of sustained virological response among treatment-naive patients was between 69% and 75%, depending on the exact regimen, according to Ira Jacobson, MD, of the Weill Cornell Medical College in New York City, and colleagues.

In contrast, just 44% of patients who got standard therapy had a sustained response, the researchers reported.

When the FDA approved the drug in May, a company spokesman told MedPage Today, the agency used a slightly different method of calculating SVR rates. As a result, the labeling for the drug says that in treatment-naive patients the best SVR rate is 79%.

Telaprevir is the second protease inhibitor to be approved for hepatitis C; earlier in May, the FDA okayed boceprevir (Victrelis).

In the REALIZE trial, researchers enrolled 663 patients with genotype 1 hepatitis C who had either not responded, had a partial response, or had relapsed after an initial response to standard therapy.

They were randomly assigned to three groups, Zeuzem and colleagues reported.

In the so-called T12PR48 group, patients got telaprevir for 12 weeks, along with peginterferon plus ribavirin, followed by peginterferon plus ribavirin alone for a total of 48 weeks of therapy.

In the "lead-in group" patients started with four weeks of peginterferon plus ribavirin followed by the T12PR48 regimen.

In the control group -- dubbed PR48 – patients were treated with peginterferon and ribavirin for 48 weeks.

The researchers found:

• SVR rates among patients who had a previous relapse were 83% in the T12PR48 group, 88% in the lead-in group, and 24% in the control group.

• Among those who had a previous partial response, the rates were 59%, 54%, and 15%, respectively.

• In those who had not responded to their first therapy, the rates were 29%, 33%, and 5%, respectively.

• The comparisons were all significant at P<0.001.

Grade three adverse events were mainly anemia, neutropenia, and leukopenia and were reported by 37% of patients in the telaprevir groups, compared with 22% in the control group.

But the most common side effects, reported by more than 25% of patients, were fatigue, pruritus, rash, nausea, influenza-like illness, anemia, and diarrhea.

The researchers were especially concerned about rash, because there have been reported cases of Stevens-Johnson syndrome among telaprevir patients. In this study, grade three rash, any skin event resulting in permanent discontinuation of study drugs, or any skin event defined as a serious adverse event occurred in 5% of patients in the two telaprevir groups, as compared with none in the control group.

The ADVANCE study, in 1,088 treatment-naive patients, also had a three-arm design, Jacobson and colleagues reported, although it was slightly more complicated.

As in the other trial, the control group was assigned to get peginterferon and ribavirin for 48 weeks, but with the addition of a placebo for the first 12 weeks.

In one active arm – dubbed T12PR – patients got all three drugs for 12 weeks, followed by peginterferon/ribavirin alone for 12 weeks if the virus was undetectable at weeks four and 12 or for 36 weeks if it was found at either point.

In the other arm, called T8PR, patients got all three drugs for eight weeks, followed by a placebo and peginterferon/ribavirin for four weeks. This was followed by either 12 or 36 weeks of peginterferon/ribavirin, based on the same criteria used in the T12PR group.

Jacobson and colleagues found:

• SVR rate in the control group was 44%, comparable with rates previously seen with standard therapy.

• SVR rate in the T12PR group was 75%, while the rate in the T8PR group was 69%. Both differences were significant from the control group at P<0.001.

• 58% of telaprevir patients responded early enough so that the treatment could be truncated to 24 weeks in total.

The researchers said the rates of nausea, diarrhea, pruritus, rash, and anemia were at least 10 percentage points higher in each of the telaprevir groups than in the control group.

Development of a rash caused 7% of patients in the T12PR group and 5% in the T8PR group to stop telaprevir, and 1.4% and 0.5%, respectively, to stop all treatment, Jacobson and colleagues reported.

Rashes were primarily eczema and were reversible with discontinuation of telaprevir, they said, noting that one case of Stevens–Johnson syndrome occurred about 11 weeks after the patient's last dose of telaprevir.

Both studies were supported by Tibotec and Vertex Pharmaceuticals. Several authors in both cases are employees of one of the companies.

Jacobson reported financial links with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Biolex Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, GlobeImmune, Human Genome Sciences, Novartis, Pharmasset, Pfizer, Roche–Genentech, sanofi-aventis, Schering-Plough (now part of Merck), Tibotec, Vertex Pharmaceuticals, and ZymoGenetics,

Zeuzem reported financial links with Abbott, Achillion Pharmaceuticals, Anadys Pharmaceuticals, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Human Genome Sciences, iTherX, Novartis, Pfizer, Pharmasset, Roche–Genentech, Santaris Pharma, Schering-Plough (Merck), Tibotec, and Vertex Pharmaceuticals.

Primary source: New England Journal of Medicine
Source reference:
Jacobson IM, et al "Telaprevir for previously untreated chronic hepatitis C virus infection" N Engl J Med 2011; 364: 2405-2416.

Additional source: New England Journal of Medicine
Source reference:
Zeuzem S, et al "Telaprevir for retreatment of HCV infection" N Engl J Med 2011; 364: 2417-2428.

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